Metformin and Vildagliptin's Kidney Protective Effect in Metabolic Syndrome Patients
This study aims to evaluate the protective effect of Metformin and Vildagliptin on the kidneys in patients with metabolic syndrome, by observing the impact on blood pressure, glucose serum levels, and insulin resistance.
Vildagliptin
+ Captopril Tablets
+ MetFORMIN 500 Mg Oral Tablet
Urogenital Diseases+13
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Treatment Study
Summary
Study start date: November 1, 2019
Actual date on which the first participant was enrolled.This study focuses on understanding the relationship between different parts of metabolic syndrome and the occurrence of kidney injury. It also aims to explore the protective effects of two antidiabetic drugs, Metformin and Vildagliptin, on the kidneys. The study is particularly interested in figuring out if this protective action is linked to their blood sugar lowering properties or if there's another mechanism at play. This research is important as it could help improve treatment strategies for metabolic syndrome and slow down the progression of kidney damage in diabetic patients. Participants in this study will be administered either Metformin or Vildagliptin. The study will then evaluate the impact of these drugs on blood pressure, a key component of metabolic syndrome. Additionally, it will assess how these medications improve patients' conditions and reduce complications of metabolic syndrome. This will be done by measuring glucose levels in the blood and insulin levels in the plasma to calculate insulin resistance. The study also aims to understand if these drugs can slow down the worsening of metabolic syndrome.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.39 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. men or women 40-70 years of age 2. body mass index be-tween≥22 and ≤40 kg/m2. 3. DM with an HbA1c ≥ 7 Exclusion Criteria: (1) pregnant or nursing women; (2) chronic (\>7 consecutive days) oral, parenteral or intra-articular corticosteroid treatment within 8 weeks prior to Visit 1 (3) history or evidence of major hepatopathy (aspartate aminotransferase or alanineaminotransferase activities \> 2.5 times the upper limit of normal) (4) ischemic heart disease or cerebrovascular disease (5) creatinine level \> 0.133 mmol/L (6) major diabetes complications (chronic renal insufficiency, proliferative retinopathy and stroke); (7) extreme dyslipidemia, such as familial hypercholesterolaemia \-
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Diabetes & Endocrinology Institute
Cairo, EgyptOpen National Diabetes & Endocrinology Institute in Google Maps